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A Simple Trick that Safety Test Labs Don�t Want You to Know!

Important Changes Made to IEC 660601-1 Test Report Form, Ver i/j

On July 4th 2014 a new version i of the IEC 60601-1 Test Report Form (TRF) was published to replace version h. Version i is like version h in that they both are used with amendment 1 of 60601-1, which requires less risk results. The difference is that it changes how to document the risk results in the TRF in hopes to be more straightforward and simpler.

The list of changes are the following:

Only one risk management (RM) result table for Clause 4.2.2 to document references to all elements of ISO 14971:2007. All other RM results tables have been removed.

The clauses that need risk results are now documented within the �Result - Remarks� column of the TRF. Remarks must include references the specific line item of the hazard analysis/FMEA, containing the hazard and the related risk control information for the specific medical device under investigation.

The end result was to simplify the risk management documentation compared to the previous 60601-1 TRF versions. For example version I has one RM table compared to version H which requires up to 80 RM Result Tables. Without RM result tables there is no more need to repeat information that added little value. This process of referencing risk results will take less time time and make it simpler for the both the customer and test laboratory.

About OBCM

Training

We're offering our 3 day IEC 60601 training course in Boston MA, 21 - 23 Oct 2014. The course continues to evolve to stay up to date with the latest standards, interpretations, regulatory guidance, and feedback from over 1000 past participants. We are now offering a 10% discount until 30 Sept. See Details and Register here.

Open House

We're celebrating our ten year anniversary this October 23rd at our Annual Open House. For the past ten years we have specialized in providing testing, consulting, and training services for IEC 60601-1, ed 3.1 and related standards for medical equipment, for our clients located worldwide. So stop by, get to know us and enjoy some good food and drink.